Project Summary Congenital Cytomegalovirus (CMV) infection is a leading cause of birth defects and developmental disabilities in the U.S., affecting thousands of children each year. Current methods (e.g., tissue culture, shell vial assay, single-copy gene PCR methods, etc.) to detect CMV infections are labor intensive and require sophisticated equipment, dedicated laboratory space, and trained technicians. A rapid, on-site test for newborn screening that could detect CMV in clinical specimens would: (1) allow for immediate counseling and additional specimen collection for confirmatory testing, and (2) avoid having to create new laboratory infrastructure for widespread biospecimen testing. We propose developing a point-of-care test for rapid screening of congenital CMV infection. This technology will also result in a significant cost reduction as compared to hospital and clinical pathology laboratory tests. The goal of this project is to develop an inexpensive ($10-15 per sample) and rapid (<30 min from specimen to result) screening assay for primary CMV infections.